SurgiCase Planner SurgiCase Knee Planner

GUDID E314SURGICASEKNEEPLAN0

SurgiCase Knee Planner

Materialise NV

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software
Primary Device IDE314SURGICASEKNEEPLAN0
NIH Device Record Key316ef4d7-a42e-4e9c-8938-015bbb96f3ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiCase Planner
Version Model NumberSurgiCase Knee Planner
Catalog NumberSurgiCase Knee Planner
Company DUNS373139427
Company NameMaterialise NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE314SURGICASEKNEEPLAN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOGKnee Arthroplasty Implantation System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-17

On-Brand Devices [SurgiCase Planner ]

E314SURGICASESHOULPLAN0SurgiCase Shoulder Planner
E314SURGICASEPLANNER0SurgiCase Planner
E314SURGICASEKNEEPLAN0SurgiCase Knee Planner

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